Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Circassia Limited
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.
Study Overview
Brief Summary
Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis. Cat-PAD is a novel, synthetic, allergen derived peptide desensitising vaccine currently being developed for treatment of cat allergy.
At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate clinical development of peptide immunotherapy vaccines, in addition to providing an improved understanding of the underlying molecular mechanisms of efficacy, thus providing new leads for therapeutic intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female, aged 18-65 years.
- •Weight >50 kg.
- •A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats.
- •Positive skin prick test to cat allergen.
- •Subjects must have regular exposure to a cat in their normal living or working circumstances throughout the course of the study.
- •Minimum qualifying rhinoconjunctivitis symptom scores
Exclusion Criteria
- •History of asthma
- •History of anaphylaxis to cat allergen
- •History of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments
- •History of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis)
Arms & Interventions
Cat-PAD
Intervention: Cat-PAD (Biological)
Outcomes
Primary Outcomes
Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.
Time Frame: 6 months following treatment
Secondary Outcomes
- Symptom scores for ocular and nasal symptoms(4 weeks following treatment)
- Interleukin production and eosinophil level changes(4 weeks following treatment)
- Functional genomic changes(4 weeks following treatment)
- Changes in urine metabolomic profiles(4 weeks following treatment)